Acute Myeloid Leukemia (AML) Clinical Trials (2026): 527 Recruiting Interventional Studies
Last updated: April 2, 2026
Current Clinical Trial Landscape
Active research areas in 2026:
- Venetoclax-based combinations (177 trials): backbone of both intensive and non-intensive regimens
- FLT3 inhibitors (55 trials): gilteritinib, quizartinib, next-gen agents in frontline and maintenance
- Menin inhibitors (40 trials): revumenib, ziftomenib, bleximenib for NPM1-mutated and KMT2A-rearranged AML
- IDH1/2 inhibitors (34 trials): ivosidenib, enasidenib combinations
- Transplant and cellular therapies (385 trials): optimized conditioning, GVHD prevention, CAR-T, post-transplant maintenance
Already approved: Venetoclax + azacitidine, midostaurin/gilteritinib/quizartinib (FLT3), ivosidenib (IDH1), enasidenib (IDH2), gemtuzumab ozogamicin (CD33), CPX-351
Recruiting Trials by Molecular Subtype
FLT3-Mutated (55 trials)
FLT3-ITD and FLT3-TKD are the most actionable mutations. Trials combine FLT3 inhibitors with venetoclax and optimize maintenance:
- NCT04293562 - CPX-351 and/or Gilteritinib vs standard chemo in newly diagnosed AML ± FLT3 mutations (Phase 3)
- NCT06577247 - Quizartinib or Placebo + Chemo in newly diagnosed FLT3-ITD negative AML (Phase 3)
- NCT05586074 - HEC73543 vs salvage chemo in relapsed/refractory FLT3-ITD AML (Phase 3)
- NCT07463651 - MRD-guided maintenance post-transplant: Gilteritinib vs Sorafenib (Phase 3)
NPM1-Mutated / KMT2A-Rearranged — Menin Inhibitors (40 trials)
The most exciting new drug class in AML. Menin inhibitors target the menin-KMT2A interaction:
- NCT07211958 - Revumenib + intensive chemo in newly diagnosed NPM1-mutated AML (Phase 3)
- NCT07007312 - Ziftomenib + Venetoclax/Azacitidine or 7+3 in untreated NPM1-m or KMT2A-r AML (Phase 3)
- NCT06851222 - Bleximenib + Venetoclax + Azacitidine in newly diagnosed AML (Phase 3)
- NCT06652438 - Revumenib + Azacitidine + Venetoclax in NPM1-mutated or KMT2A-rearranged AML (Phase 3)
IDH1/IDH2-Mutated (34 trials)
- NCT07075016 - Ivosidenib + Azacitidine ± Venetoclax in newly diagnosed IDH1-mutated AML ineligible for intensive chemo (Phase 3)
- NCT06387069 - HMPL-306 (dual IDH1/2 inhibitor) in IDH1 or IDH2-mutated AML (Phase 3)
- NCT05907057 - Ivosidenib + Azacitidine in newly diagnosed IDH1m AML (Phase 3b)
TP53-Mutated (14 trials)
The highest unmet need in AML — TP53-mutated disease has extremely poor prognosis with current therapies. Multiple novel agents in development.
Trials by Treatment Setting
Newly Diagnosed — Intensive (Fit Patients)
- NCT04628026 - Induction and consolidation chemo with Venetoclax in newly diagnosed AML/MDS-EB-2 (Phase 3)
- NCT05805098 - Venetoclax + Homoharringtonine + Cytarabine induction (Phase 3)
- NCT06810791 - HVA vs IA/DA or VA in high-risk AML (Phase 3)
- NCT05939180 - VA vs DA for newly diagnosed high-risk AML (Phase 3)
- NCT02416388 - Daunorubicin vs high-dose Idarubicin, intermediate vs high-dose cytarabine (Phase 3)
- NCT04168502 - Gemtuzumab ozogamicin MRD-guided in favorable/intermediate risk AML (Phase 3)
Newly Diagnosed — Non-Intensive (Unfit/Elderly)
- NCT06389292 - Lisaftoclax (APG-2575, next-gen BCL-2) + Azacitidine in AML (Phase 3)
- NCT04256317 - AZTOUND: ASTX030 (oral azacitidine) ± Venetoclax (Phase 3)
- NCT07132684 - VA vs D/IA induction in elderly fit AML (Phase 3)
- NCT06345365 - MA + AZA regimen for newly diagnosed AML (Phase 3)
Relapsed / Refractory
- NCT06713837 - IMPACT-AML: Pragmatic clinical trial for R/R AML (Phase 3)
- NCT06418776 - IMPACT-AML: Randomized pragmatic trial for R/R AML (Phase 3)
- NCT06788756 - L-Annamycin + Cytarabine second-line remission induction (Phase 3)
- NCT05726110 - Selinexor + HAD or CAG in R/R AML (Phase 3)
Maintenance / Post-Remission
- NCT05404906 - Azacitidine + Venetoclax maintenance in younger adults with AML in first remission (Phase 3)
- NCT06972641 - Molecular genetics-guided maintenance after allo-HSCT (Phase 3)
- NCT06802718 - Interferon-alpha maintenance for favorable-risk AML (Phase 3)
- NCT06990321 - Medium-dose cytarabine + Venetoclax consolidation in elderly intermediate/high-risk AML (Phase 3)
Transplant Optimization
- NCT04314219 - Post-transplant cyclophosphamide vs SOC GVHD prophylaxis (Phase 3)
- NCT05429632 - Mocravimod adjunctive and maintenance in AML patients undergoing allo-HCT (Phase 3)
- NCT04708054 - Venetoclax to improve outcomes of busulfan conditioning in high-risk AML/MDS (Phase 3)
- NCT03793517 - Decitabine + mBU/CY for high-risk acute leukemia with MRD pre-HSCT (Phase 3)
Novel Approaches
- Menin inhibitors: Revumenib, ziftomenib, bleximenib — first targeted therapy for NPM1-mutated AML (30% of AML), all reaching Phase 3 in 2026
- Next-gen BCL-2 inhibitors: Lisaftoclax (APG-2575), sonrotoclax — designed to improve on venetoclax
- Dual IDH inhibitors: HMPL-306 targeting both IDH1 and IDH2 mutations with a single agent
- MRD-guided therapy: Multiple trials using measurable residual disease to guide maintenance and transplant decisions
- Oral azacitidine combinations: ASTX030 (cedazuridine + azacitidine) enabling fully oral regimens
- Pediatric AML: NCT05183035 - Venetoclax in children with R/R AML; NCT05994690 - CHIP-AML22 master protocol
Trial listings from ClinicalTrials.gov. Page summaries generated by AI and may contain errors. Always verify with your healthcare provider.
Frequently Asked Questions
How do I find AML clinical trials for my mutation?
Paste your medical summary into ClinTrialFinder to get AI-matched AML trials in minutes. The tool considers your FLT3-ITD/TKD status, IDH1/IDH2 mutations, NPM1 status, KMT2A rearrangements, TP53 mutations, cytogenetic risk group, and prior treatments including transplant history.
What AML trials are currently recruiting?
There are 527 recruiting interventional trials for AML including venetoclax-based combinations (177), FLT3 inhibitors (55), menin inhibitors for NPM1/KMT2A (40), IDH1/2 inhibitors (34), TP53-directed therapies (14), and transplant/cellular approaches (385).
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